Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder
Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder
According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse effects were observed due to oral low-dose AD04 treatment. The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events (AEs), high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.Findings underscore the liver safety of AD04 as compared to placebo in the prior Phase 3 clinical trial
研究结果突显了先前的3期临床试验中与安慰剂相比，AD04的肝脏安全性
GLEN ALLEN, Va., April 10, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company's lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company's prior Phase 3 clinical trial.
弗吉尼亚州格伦艾伦，2024年4月10日（GLOBE NEWSWIRE）——专注于开发治疗和预防成瘾及相关疾病疗法的临床阶段生物制药公司Adial Pharmicals, Inc.（纳斯达克股票代码：ADIL）（“Adil” 或 “公司”）宣布发表了一篇经过同行评审的文章，重点介绍了服用AD04（低）患者的临床结果、良好的安全性以及高依从性 dose ondansetron），该公司正在开发的用于治疗酒精使用的主要研究性新药产品失调（澳元）。该出版物还报告了一项新研究的结果，该研究分析了该公司先前的3期临床试验中AD04与安慰剂对比的肝脏安全性。
The published study provides a comprehensive analysis of the liver safety profile of AD04 compared to a placebo in individuals with AUD and a specific 5-marker genetic profile. AUD, characterized by compulsive alcohol consumption and loss of control over intake, poses significant health risks and is a major contributor to alcohol-associated liver disease (ALD), a leading cause of liver transplantation and global mortality.
已发表的研究全面分析了AUD患者和特定的5标记遗传特征患者中AD04与安慰剂相比的肝脏安全概况。澳元以强迫性饮酒和失去摄入控制为特征，构成严重的健康风险，是酒精相关性肝病（ALD）的主要病因，酒精相关肝病是肝移植和全球死亡的主要原因。
According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse effects were observed due to oral low-dose AD04 treatment. The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events (AEs), high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.
根据该出版物，低剂量AD04没有显著改变肝损伤的生化标志物，例如ALT、AST和血清胆红素。此外，虽然AUD患者表现出GGT水平升高，通常与饮酒量增加有关，但该参数仍未受到低剂量AD04的影响。此外，口服低剂量AD04治疗未观察到明显的不良反应。该出版物还强调，与安慰剂相比，低剂量AD04表现出优异的安全性和耐受性，不良事件（AE）发生率低，药物依从性高，辍学率最低。作者进一步指出，酒精文献中没有一项研究表明有效的药物表现出与安慰剂相似的AE特征。
The manuscript entitled, "Safety and compliance of long-term low-dose ondansetron in alcohol use disorder treatment," was published in the European Journal of Internal Medicine. The publication is available via Open Access at:
这份题为 “长期低剂量恩丹西酮在酒精使用障碍治疗中的安全性和合规性” 的手稿发表在《欧洲内科医学杂志》上。该出版物可通过开放获取获取，网址为：
Cary Claiborne, CEO of Adial, commented, "Current pharmacological treatments for AUD are limited by low efficacy, poor adherence and adverse effects. This peer-reviewed publication emphasizes the safety and potential of AD04 in addressing the critical needs of individuals suffering from AUD and ALD. With this significant milestone, we are one step closer to providing a precision treatment option that could make a profound impact on the lives of millions worldwide."
Adial首席执行官Cary Claiborne评论说：“目前的澳元药物治疗因疗效低、依从性差和不良反应而受到限制。这份经过同行评审的出版物强调了AD04在满足澳元和ALD患者的关键需求方面的安全性和潜力。有了这个重要的里程碑，我们离提供可能对全球数百万人的生活产生深远影响的精准治疗选择又近了一步。”
"This study report further supports prior data showing that AD04 treatment does not pose significant health risks in patients with AUD. AD04 was well tolerated, and no treatment related serious adverse events were observed. AD04 treatment was not associated with significant changes in liver biochemical parameters, cardiac events, or general well-being. Most importantly, the publication highlighted the potential of AD04 for the treatment for AUD among patients with a specified genetic background. Ultimately, we believe AD04 could pave the way for precision treatments tailored to individuals with AUD, offering a novel strategy to not only manage alcohol consumption but also mitigate liver damage in affected populations," concluded Claiborne.
“这份研究报告进一步支持先前的数据，这些数据表明，AD04治疗不会对澳元患者构成重大健康风险。AD04耐受性良好，未观察到与治疗相关的严重不良事件。AD04 治疗与肝脏生化参数、心脏事件或总体健康状况的显著变化无关。最重要的是，该出版物强调了AD04在具有特定遗传背景的患者中治疗AUD的潜力。最终，我们相信AD04可以为针对澳元患者量身定制的精准治疗铺平道路，提供一种新策略，不仅可以管理酒精消费，还可以减轻受影响人群的肝损伤，” 克莱伯恩总结道。